Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies

Abstract

ObjectiveOverview on risks of acupuncture-related adverse events (AEs).DesignSystematic review and meta-analyses of prospective studies.Data sourcesPubMed, Scopus and Embase from inception date to 15 September 2019.Eligibility criteria for selecting studiesProspective studies assessing AEs caused by needle acupuncture in humans as primary outcome published in English or German.Data extraction and synthesisTwo independent researchers selected articles, extracted the data and assessed study quality. Overall risks and risks for different AE categories were obtained from random effects meta-analyses.Main outcomesOverall risk of minor AEs and serious adverse events (SAEs) per patients and per treatments.ResultsA total of 7679 publications were identified. Twenty-two articles reporting on 21 studies were included. Meta-analyses suggest at least one AE occurring in 9.31% (95% CI 5.10% to 14.62%, 11 studies) of patients undergoing an acupuncture series and in 7.57% (95% CI 1.43% to 17.95%, 5 studies) of treatments. Summary risk estimates for SAEs were 1.01 (95% CI 0.23 to 2.33, 11 studies) per 10 000 patients and 7.98 (95% CI 1.39 to 20.00, 14 studies) per one million treatments, for AEs requiring treatment 1.14 (95% CI 0.00 to 7.37, 8 studies) per 1000 patients. Heterogeneity was substantial (I2 >80%). On average, 9.4 AEs occurred in 100 treatments. Half of the AEs were bleeding, pain or flare at the needle site that are argued to represent intended acupuncture reaction. AE definitions and assessments varied largely.ConclusionAcupuncture can be considered among the safer treatments in medicine. SAEs are rare, and the most common minor AEs are very mild. AEs requiring medical management are uncommon but necessitate medical competence to assure patient safety. Clinical and methodological heterogeneity call for standardised AE assessments tools, clear criteria for differentiating acupuncture-related AEs from therapeutically desired reactions, and identification of patient-related risk factors for AEs.PROSPERO registration numberCRD42020151930.

Safety of acupuncture in oncology: A systematic review and meta‐analysis of randomized controlled trials

“…1). 1‐134 Of those, 65 of 94 publications (69.1%) were included in the qualitative analysis because they reported at least 1 type of AE,…”

“…In a current meta-analysis by Baumler et al of different patient populations, the authors found that an AE can be expected in every 10th patient or at every 13th acupuncture treatment. 15 Most of the AEs were minor and transient or even intended effects, indicating a favorable physiological response. Serious AEs were very rare.…”

“…10,11 One meta-analysis of prospective clinical trials on acupuncture-related AEs included 11 studies with a total of 845,637 patients. 15 In that analysis, the overall risk of at least 1 acupuncture-related AE during a series of acupuncture treatments was estimated to be 9.31 per 100 patients treated.…”

“…In both observational studies, local pain from needling, bruising, minor bleeding, and orthostatic problems were the most common side effects 10,11 . One meta‐analysis of prospective clinical trials on acupuncture‐related AEs included 11 studies with a total of 845,637 patients 15 . In that analysis, the overall risk of at least 1 acupuncture‐related AE during a series of acupuncture treatments was estimated to be 9.31 per 100 patients treated.…”

Wen Dan Tang: A Potential Jing Fang Decoction for Headache Disorders?

“…Although the exact mechanism of acupuncture is difficult to research and not yet completely understood, clinical trials have shown good evidence of acupuncture efficacy in the treatment of HD and for the prevention of migraine, TTH, or chronic HD [ 224 ]. As adverse events are mild and serious adverse events are rare, acupuncture can be considered a safe treatment [ 225 ].…”